CQ Specialist QMS/Compliants

Johnson Johnson; Warszawa; On-site; PLN 60,000 - 90,000; Full time

Job summary

Johnson & Johnson in Warsaw, Poland is recruiting a CQ Specialist focused on QMS and complaints handling. You will support the quality management system, document and process product complaints, and assist in regulatory reporting and post‑market activities to ensure patient safety and compliance.

The role emphasizes cross‑functional collaboration across Manufacturing, R&D, Regulatory Affairs, and Customer Service, with exposure to global quality processes in a regulated medical device

Qualifications

• Bachelor's degree in a scientific, engineering, quality, or related discipline.
• Advanced degree in Quality, Regulatory, or Life Sciences preferred.
• 0–2 years of professional experience in Quality, Regulatory, Compliance, or a regulated industry environment.
• Foundational knowledge of Quality Management Systems and controlled documentation.
• Strong attention to detail and ability to manage quality records accurately.
• Languages: English required; Polish required for local operations.
• Experience with ISO 13485, FDA QSR, EU MDR preferred.
• Experience with electronic QMS or complaint management systems.

Responsibilities

• Support the execution and maintenance of the Quality Management System (QMS) in alignment with internal procedures and applicable global regulations.
• Process, document, and track product complaints in accordance with regulatory and internal requirements, ensuring timely and accurate resolution.
• Support complaint investigation activities, including data collection, trend analysis, documentation of findings, and follow‑up of required actions.
• Support regulatory reporting activities related to complaints, adverse events, and vigilance requirements, as applicable.
• Support Field Actions, Recalls, and other post‑market quality activities by maintaining documentation, tracking actions, and supporting execution in accordance with internal and regulatory requirements.
• Maintain accurate quality records and ensure data integrity within quality systems and databases.
• Support the execution of other QMS elements and quality processes as assigned, in accordance with company procedures.
• Participate in audits, inspections, and internal assessments by preparing documentation and supporting responses.
• Analyze complaint and quality data to identify trends, gaps, potential risks, and opportunities for continuous improvement within complaint and QMS processes.
• Collaborate with cross‑functional partners, including Manufacturing, R&D, Regulatory Affairs, and Customer Service, to support quality outcomes and effective issue resolution.
• Contribute to continuous improvement initiatives that strengthen QMS effectiveness, regulatory compliance, patient safety, and product quality.

Skills

Quality Assurance

Regulatory Compliance

Data Analysis

Documentation

English Proficiency

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Tools

Electronic QMS

Complaint Management System

Job description

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations

Prague, Czechia, Warsaw, Masovian, Poland

Job Description

DePuy Synthes is recruiting for a CQ Specialist QMS/Compliants, located in Warsaw Poland.

Job Overview

The CQ Specialist, QMS / Complaints plays a critical role within QARA International by supporting the effectiveness and compliance of the Quality Management System (QMS), focusing on end ‑ to ‑ end handling of product complaints, vigilance, field action/recall and supporting the execution of other QMS elements. This role directly supports patient safety, regulatory compliance, and continuous improvement across DePuy Synthes' international markets. The position offers strong exposure to global and local quality processes, cross ‑ functional collaboration, and regulated medical device environments.

Key Responsibilities

• Support the execution and maintenance of the Quality Management System (QMS) in alignment with internal procedures and applicable global regulations.
• Process, document, and track product complaints in accordance with regulatory and internal requirements, ensuring timely and accurate resolution.
• Support complaint investigation activities, including data collection, trend analysis, documentation of findings, and follow‑up of required actions.
• Support regulatory reporting activities related to complaints, adverse events, and vigilance requirements, as applicable.
• Support Field Actions, Recalls, and other post‑market quality activities by maintaining documentation, tracking actions, and supporting execution in accordance with internal and regulatory requirements.
• Maintain accurate quality records and ensure data integrity within quality systems and databases.
• Support the execution of other QMS elements and quality processes as assigned, in accordance with company procedures.
• Participate in audits, inspections, and internal assessments by preparing documentation and supporting responses.
• Analyze complaint and quality data to identify trends, gaps, potential risks, and opportunities for continuous improvement within complaint and QMS processes.
• Collaborate with cross‑functional partners, including Manufacturing, R&D, Regulatory Affairs, and Customer Service, to support quality outcomes and effective issue resolution.
• Contribute to continuous improvement initiatives that strengthen QMS effectiveness, regulatory compliance, patient safety, and product quality.

Qualifications

Education

Bachelor's degree required in a scientific, engineering, quality, or related discipline.

Advanced degree in Quality, Regulatory, or Life Sciences preferred.

Experience and Skills

Required:

Typically 0-2 years of professional experience in Quality, Regulatory, Compliance, or a regulated industry environment.

Foundational knowledge of Quality Management Systems and controlled documentation.

Strong attention to detail and ability to manage quality records accurately.

Ability to analyze data, identify trends, and support root ‑ cause activities at a basic level.

Effective written and verbal communication skills.

Preferred:

Experience supporting medical device or pharmaceutical complaint handling processes.

Familiarity with global quality and regulatory standards (e.g., ISO 13485, FDA QSR, EU MDR).

Experience working with electronic QMS or complaint management systems.

Experience in an international or matrixed organization.

Other:

Languages: Proficiency in English required ; Polish required for local operations.

Travel: Minimal travel anticipated ( generally 10%, international as needed).

Certifications: Quality or Regulatory certifications (e.g., ASQ) preferred but not required.

Company Information

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Company Update

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal require